Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth

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Persistent link to this item

http://dx.doi.org/10.13020/D6KW2D
https://hdl.handle.net/11299/160551

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Keywords

Periodontal therapy

Pre-term birth

Randomized controlled trial

Periodontal measurements

Pregnant women

Collection period

Date completed

2009

Date updated

Time period coverage

Geographic coverage

Source information

Journal Title

Journal ISSN

Volume Title

Title

Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth

Published Date

2013-11-22

Authors

Hodges, James S

Michalowicz, Bryan S

Group

Author Contact

Hodges, James S.
hodge003@umn.edu

Type

Dataset
Experimental Data

Abstract

The OPT Study was a multi-center randomized, single-blind (examiners) controlled clinical trial testing whether mechanical periodontal therapy (scaling and planing) in pregnant women at risk for premature birth reduced the extent or severity of premature birth. OPT found that periodontal therapy does not reduce the number or timing of premature births. Data include birth outcomes (including gestational age, birthweight, presence of congenital anomalies, and 1 and 5 minute APGAR scores), baseline characteristics (including previous pregnancy outcomes), periodontal therapy and essential dental care delivered as part of the study, maternal conditions during pregnancy, and the following items for three visits between the end of the first trimester and delivery: clinical periodontal measurements (pocket depth, attachment loss, and bleeding on probing at 6 sites per tooth; site-specific data and several common person-level summaries), medications, dental plaque levels of 8 bacterial species, levels of serum antibodies for the same 8 bacterial species, and serum levels of 8 inflammatory markers or mediators. The OPT Study's Manual of Procedures (Version 1) is available as part of this package. Version changes during the course of the study were rare and affected very few data items (mostly the data describing study periodontal therapy). The OPT Study team published the main paper in 2006 in the New England Journal of Medicine and has published 8 secondary papers.

Description

The collected data are documented in the Data Dictionary and the Manual of Practice files. Citations using the data are included in a text file.

Referenced by

Michalowicz BS, Hodges JS, DiAngelis AJ, Lupo VR, Novak MJ, Ferguson JE, Buchanan W, Bofill J, Papapanou PN, Mitchell DA, Matseoane S, Tschida PA; OPT Study. (2006). Treatment of periodontal disease and the risk of preterm birth. N Engl J Med. 2006 Nov 2; 355 (18). p1885-94.
http://dx.doi.org/10.1056/NEJMoa062249

Related to

Replaces

License

Publisher

Collections

Data Repository for U of M (DRUM)
Data Curation Pilot Project, 2013

Funding information

The data in these files were collected during the OPT Study funded by the National Institute of Dental and Craniofacial Research, grant number DE014338. The ClinicalTrials.gov number is NCT00066131.

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Previously Published Citation

Suggested citation

Hodges, James S; Michalowicz, Bryan S. (2013). Data from the Obstetrics and Periodontal Therapy (OPT) Study, a Randomized Trial of Periodontal Therapy to Prevent Pre-term Birth. Retrieved from the Data Repository for the University of Minnesota (DRUM), http://dx.doi.org/10.13020/D6KW2D.

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